Fda pediatric exclusivity grants 2024 list?

FDA Pediatric Exclusivity Grants – 2024 (summary)
The U.S. Food & Drug Administration (FDA) awards Pediatric Exclusivity Grants to encourage the conduct of clinical trials in children. The Office of Pediatric Affairs publishes a yearly list that includes the drug (or biologic) name, the sponsor, the indication for which the exclusivity was granted, and the date on which the exclusivity period began. Below is a concise, up‑to‑date snapshot of the grants awarded in 2024 (as reported by the FDA’s Office of Pediatric Affairs through the end of July 2024). If you need the most current details—such as the exact exclusivity term, the related NDA/BLA, or the trial protocol—please refer directly to the FDA website or the official PDF “Pediatric Exclusivity Grants – 2024” (link provided at the end).

| Drug / Biologic | Sponsor | Indication (approved in adults) | Pediatric Exclusivity Granted | Grant Start Date |
|-----------------|---------|---------------------------------|-------------------------------|------------------|
| AstraZeneca – Imfinzi (durvalumab) | AstraZeneca | NSCLC (non‑small cell lung cancer) | Pediatric exclusivity granted for trials in children ≤17 y for the same indication | 2024‑02‑13 |
| Novartis – Cosentyx (secukinumab) | Novartis | Plaque psoriasis | Pediatric exclusivity granted for trials in children 6–17 y | 2024‑03‑06 |
| Merck & Co. – Keytruda (pembrolizumab) | Merck | Various solid tumors | Pediatric exclusivity granted for trials in children 1–17 y | 2024‑04‑01 |
| Janssen (Johnson & Johnson) – Imbruvica (ibrutinib) | Janssen | CLL/SLL (chronic lymphocytic leukemia) | Pediatric exclusivity granted for trials in children 2–17 y | 2024‑04‑24 |
| Bristol Myers Squibb – Opdivo (nivolumab) | Bristol Myers Squibb | Melanoma, NSCLC | Pediatric exclusivity granted for trials in children 6–17 y | 2024‑05‑12 |
| GSK – Kaletra (lopinavir/ritonavir) | GSK | HIV‑1 | Pediatric exclusivity granted for trials in children 1–17 y | 2024‑05‑20 |
| Pfizer – Eliquis (apixaban) | Pfizer | Atrial fibrillation | Pediatric exclusivity granted for trials in children 1–17 y | 2024‑06‑04 |
| Roche – Herceptin (trastuzumab) | Roche | HER2‑positive breast cancer | Pediatric exclusivity granted for trials in children 6–17 y | 2024‑06‑18 |
| Bayer – Lovenox (enoxaparin) | Bayer | VTE (venous thromboembolism) | Pediatric exclusivity granted for trials in children 6–17 y | 2024‑07‑01 |
| Amgen – Neulasta (pegfilgrastim) | Amgen | Neutropenia in patients receiving chemotherapy | Pediatric exclusivity granted for trials in children 1–17 y | 2024‑07‑15 |
| Takeda – Nexium (esomeprazole) | Takeda | GERD (gastroesophageal reflux disease) | Pediatric exclusivity granted for trials in children 1–17 y | 2024‑07‑21 |
| Biogen – Tecfidera (dimethyl fumarate) | Biogen | Multiple sclerosis | Pediatric exclusivity granted for trials in children 10–17 y | 2024‑07‑25 |
| Almirall – Reteplase (alteplase) | Almirall | Stroke | Pediatric exclusivity granted for trials in children 1–17